A 24-Hour Pharmacokinetic Determination of BG00012 After Single-Day Oral Administration in Subjects With MS

• Status: Completed
• Trial end date: 2009-10-31
• Target enrollment: 0
• Participant gender: All

Summary

To establish a pharmacokinetic (PK) profile of BG00012, as measured by its primary metabolite, monomethyl fumarate (MMF), during a 24-hour dosing period in subjects with relapsing-remitting multiple sclerosis (RRMS), with a variety of baseline demographic characteristics.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biogen
• Treatments: Dimethyl Fumarate

Criteria

Inclusion Criteria:

1. Aged 18 to 55 years old, inclusive, at the time of informed consent.

2. Have a confirmed diagnosis of RRMS according to McDonald criteria #1-4.

3. Be ambulatory.

Exclusion Criteria:

1. Primary progressive, secondary progressive, or progressive-relapsing multiple sclerosis (PRMS).

2. History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic (other than MS), dermatologic, psychiatric, renal, oncologic, anaphylaxis or other major diseases, as determined by the Investigator.

3. Current enrollment in any other drug, biologic, or device study or treatment with another investigational drug within 6 months or 5 half-lives of the investigational product, whichever time period is longer.

4. Serious infection (e.g., pneumonia, septicemia) within the 2 months prior to Day -1.

5. Pregnant or nursing women.

Other protocol-defined inclusion/exclusion criteria may apply.